| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00909-1 |
| Product Name/Description |
GF-UCT180 Ultrasonic Gastrovideoscope
ARTG Number: 145874 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/09/2015 |
| Responsible Entity |
|
| Reason/Issue |
The nature of this product correction is to issue a revised Instruction for Use (IFU) which includes instructions on how to correctly clean the device. There is a risk of patient-to-patient infection if the device is not cleaned appropriately.
Key changes in the new Instruction for Use are highlighted below:
· Inclusion of instruction on how to attach the cleaning adapter (MAJ-350) to the instrument channel port of the GF-UCT180
· The balloon applicator (MAJ-675) and the cleaning brush (MAJ-1534) are to be reprocessed for reuse. The MAJ-675 and MAJ-1534 are to be reprocessed in accordance with step “Cleaning, disinfection, and sterilisation procedures for reusable parts and reprocessing equipment” |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Olympus is advising their customers of the amendments to the IFU. Customers can request a new IFU by contacting Olympus. Hospitals are advised that a review of internal hospital protocols should be conducted to ensure compliance with the updated cleaning instructions. This action has been closed-out on 29/08/2016. |
| Contact Information |
(03) 9265 5435 - Olympus Australia |